Harsh sales restrictions on the once-popular diabetes medication Avandia have been lifted by the FDA. Use of the drug will no longer be limited to certain patients, and new labeling will be pretty much in-line with other prescription diabetes meds. Maybe you’re reading this and asking yourself, “Hey, isn’t the FDA sort of doing a complete 180 on Avandia?” Not a bad question.
The restrictions have been in place since 2010, when, on the heels of a study that linked Avandia use to an increase in heart problems, the FDA ordered that Avandia only be prescribed to certain diabetes patients whose condition could not be adequately controlled with any other medication.
The FDA wasn’t done with Avandia in 2010. The following year, the agency announced that the drug would no longer be available through retail pharmacies, and that only a very limited number of patients would still be able to receive it. Those patients needed to be enrolled in a special program before receiving Avandia via mail order, from specially-certified pharmacies.
So, why the regulatory change of heart now? A recent clinical trial suggested that Avandia use actually comes with no elevated risk of heart attack or death when compared with other diabetes drugs. Not that the new study was without controversy — check out this Wall Street Journal article featuring a few barbs from critics of the trial and the way it was carried out.
It sounds like Avandia’s new labeling will be pretty standard, according to the FDA announcement: “The FDA anticipates that the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus, an indication similar to other diabetes drugs currently available.”